US approves first generic EpiPen after being put on drug shortage list

The US Food and Drug Administration (FDA) has approved a generic version of the EpiPen after the drug was placed on its shortage list in May.

The injectable is used as a life-saving emergency treatment for adults and children suffering an allergic reaction to insect bites, food, medicines, pets, latex, and other causes. It contains epinephrine, more commonly known as adrenaline, which relaxes muscles in an obstructed airway, tighten up blood vessels, and reduce swelling that comes with an allergic reaction.

The EpiPen approval is for Teva Pharmaceutical Industries generic version of Mylan’s original product.

"We're applying our full resources to this important launch in the coming months and eager to begin supplying the market," Teva’s North American vice president Brendan O'Grady said in a statement to CNN.

The approval comes two years after the price of the original version from Mylan skyrocketed by 400 per cent, to nearly $600 per pack of two single-use pens.

The high price had led many patients to rely on expired products and in May the drug was put on the FDA’s drug shortage list.

With the approval, those needing the EpiPen can substitute for the cheaper generic version at pharmacies.

Partly because of the price increase, there had been “limited availability of EpiPen in certain areas in the US, including both pharmacy-level supply disruptions and a manufacturer issue,” FDA spokesperson Theresa Eisenman said.

It also comes at a time when children head back to school after summer holidays, a peak time for purchase of the medicine.

However, an exact date of availability on the market has not been set as yet.

FDA Commissioner Dr Scott Gottlieb said in a statement: "Today's approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the US is part of our longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval”.

While other brands like Adrenaclick and Auvi-Q from drugmaker Sanofi have made similar auto-injectables, they work differently, cannot be used interchangeably like a generic version, and the Teva version will be the only non-brand one on the market.